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Gut Health and the Effect on Substance and Alcohol Cravings

Gut Health and the Effect on Substance and Alcohol Cravings

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06026982
Enrollment
30
Registered
2023-09-07
Start date
2023-09-30
Completion date
2023-10-31
Last updated
2023-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craving

Keywords

gut health, substance craving, alcohol craving

Brief summary

Gut health has been linked with improvement in mental health but no research has been done to evaluate if improving gut health can have an effect on alcohol and substance cravings. This pilot study is to evaluate if any decrease in cravings can be found with probiotics/prebiotics by improving gut health. Participants will take a pre-survey to evaluate their cravings. Participants will then be started on a regimen of probiotic and prebiotic with a pickle daily for 30 days to improve gut health. Then participants will take the same survey to evaluate if there has been any decrease in cravings.

Detailed description

Consent and a pre survey on cravings will be collected. Then participants will take a probiotic/prebiotic and a pickle for 30 days. Participants will be given a probiotic formula by Rugby Health that has Bacillus Coagulans spores 1billion colony forming unit and inulin 250mg along with a pickle daily for 30 days. After 30 days the same survey will be taken by the participants and a paired t test will be used to analyze if there is a statistical change in cravings. Participants will be in a recovery program with a prior history of substance or alcohol abuse and will be abstaining from drugs and alcohol. The purpose of the study is to evaluate if improving gut health by the above intervention can also decrease substance and alcohol cravings. Probiotics and prebiotics have been shown to improve mental health with a decrease in depression and PTSD but no studies have investigated if improving gut health can decrease substance or alcohol cravings. Probiotics are a cheap intervention that many recovery centers with limited recourses would be able to use. Fermented foods like pickles have been shown to have significant benefit to gut health with improvement in the gut biome. Pickles are also affordable which is why this combination was chosen to be studied.

Interventions

DIETARY_SUPPLEMENTprobiotic and pickle

probiotic formula by Rugby Health that has Bacillus Coagulans spores 1billion CFU and inulin 250mg along with a pickle

Sponsors

City Rescue Mission Medical Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Consent and a pre survey on cravings will be collected. Then participants will take a probiotic/prebiotic and a pickle for 30 days. After 30 days the same survey will be taken by the participants and a paired t test will be used to analyze if there is a statistical change in cravings.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Males and females age 18-75 years old * current cravings for substance or alcohol use * enrolled in a recovery clinic * able to understand and comply with the requirements of the study * provision of written informed consent.

Exclusion criteria

* Any alcohol or substance use in the past week * any narcotic use (including methadone and buprenorphine) * daily probiotic product use in the last 2 weeks * women who are pregnant or planning to become pregnant during the trial * if they already have no alcohol or substance cravings * non English speakers.

Design outcomes

Primary

MeasureTime frameDescription
Decrease in substance or alcohol cravings30 daysEvaluation via the same survey before and after probiotic and a pickle for 30 days to see if there is any change in cravings. A pre and post survey will be administered with cravings rated with a scale of 1-5, no cravings would be the number one to extreme cravings with a number of 5. A paired t-test will then be used to analyze the data.

Contacts

Primary ContactAnna M McCarthy, MD, MPH
annamarie5092@gmail.com9049554247

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026